MAUDE Adverse Event Report: CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC. MICOR LENS FRAGMENTATION SYSTEM; PHACOFRAGMENTATION SYSTEM

Model Number FG-50621

Device Problem Use of Device Problem (1670)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Foreign Body In Patient (2687)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

The micor extractor was returned to the manufacturer and evaluated.The device was subjected to visual inspection, functional testing, and then disassembled for internal inspection.There was no damage or device defect identified and the device met specifications.The device had dried viscoelastic present inside the cutter tube (normal use condition) that prevented the device from aspirating during functional testing.There was no alleged malfunction and no device malfunction identified during the device evaluation.This conclusion is consistent with the event reported by the surgeon who attributed the capsular tear and sequelae to the surgical technique employed, which placed additional pressure on the posterior capsule and compromised the integrity.The micor extractor device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The device labeling identifies capsular rupture as an inherent safety risk.Manufacturer's reference #: (b)(4).

Event Description

A 71-year-old patient underwent cataract surgery on (b)(6) 2023 where the micor lens fragmentation system (extractor and drive) was used to remove the cataractous lens.The patient's posterior capsule tore during surgery.The tear occurred while using the micor extractor during removal of the lens epinucleus.There was vitreous fluid loss and the lens dropped into the vitreous cavity.An anterior vitrectomy was performed and no intraocular lens was implanted.The patient was referred to a retina specialist to address the dropped nucleus and implant a sulcus-fixated intraocular lens.At the one-day postoperative visit, the patient's best corrected visual acuity was 20/25.Additional information was requested from the surgeon which revealed the cause was attributed to surgical technique where an aggressive vertical-chop technique was employed.There were no device performance problems with the micor system.

• Brand Name: MICOR LENS FRAGMENTATION SYSTEM
• Type of Device: PHACOFRAGMENTATION SYSTEM
• Manufacturer (Section D): CARL ZEISS MEDITEC CATARACT TECHNOLOGY INC.; 8740 technology way; reno NV 89521
• Manufacturer (Section G): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8740 technology way; reno NV 89521
• Manufacturer Contact: andrew rybold ; 8740 technology way; reno, NV 89521 ; 9255959817
• MDR Report Key: 16969743
• MDR Text Key: 315669417
• Report Number: 3012123033-2023-00001
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00860000122368
• UDI-Public: 00860000122368
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: FG-50621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR